TUKYSA Added to First-Line Maintenance Therapy Extends Median Progression-Free Survival by Over 8 Months in Patients with HER2+ Metastatic Breast Cancer
View original at finance.yahoo.comTUKYSA Added to First-Line Maintenance Therapy Extends Median Progression-Free Survival by Over 8 Months in Patients with HER2+ Metastatic Breast Cancer TUKYSA, trastuzumab, and pertuzumab reduced the risk of disease progression or death by 36% compared to trastuzumab and pertuzumab alone in Phase 3 HER2CLIMB-05 study…
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The key secondary endpoint of overall survival was not mature at the time of the analysis (20% of the required events have occurred to date) but showed a numerical trend for improvement with TUKYSA
80% confidenceA PFS benefit was observed across all prespecified patient subgroups, including de novo or recurrent diagnosis, hormone receptor-positive or HR-negative disease, and with or without the presence or history of brain metastases at baseline
80% confidenceTUKYSA has become a trusted standard of care for patients with later-line HER2-positive metastatic breast cancer, and the results from HER2CLIMB-05 support its potential use as part of a chemotherapy-free, front-line maintenance strategy
80% confidenceTUKYSA in combination with trastuzumab and pertuzumab demonstrated a safety profile generally consistent with the established safety profiles of each individual therapy, except for a higher rate of asymptomatic Grade ≥3 liver transaminases
80% confidenceFirst-line standard-of-care maintenance treatment has remained unchanged since 2012, and the majority of patients with HER2+ MBC face disease progression within two years of initiating therapy
80% confidenceThe median progression-free survival was 24.9 months in the TUKYSA arm and 16.3 months in the placebo arm, representing an extension in median PFS of 8.6 months
80% confidenceAdding tucatinib to first-line maintenance therapy extends the time patients live without their disease progressing, while maintaining a manageable safety profile, suggesting a promising new potential approach that could advance the current standard of care
80% confidenceHER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate for HER2+ MBC of 41-47%, depending on HR status
80% confidenceTUKYSA is currently approved in more than 50 countries
80% confidenceTUKYSA, trastuzumab, and pertuzumab reduced the risk of disease progression or death by 35.9% compared to trastuzumab and pertuzumab alone (hazard ratio of 0.641, 95% CI: 0.514-0.799; 2-sided p<0.0001)
80% confidenceMost patients with HER2-positive metastatic breast cancer face disease progression within two years of starting first-line treatment, often requiring a transition to chemotherapy
80% confidence